− CLIMATE — Artificial intelligence is often associated with ludicrous amounts of electricity, and therefore planet-heati…+ EDUCATION — While many schools in England have banned smartphones, in Estonia – regarded as the new European education po…− EDUCATION — In a Cambridge classroom, Joseph, 10, trained his AI model to discern between drawings of apples and drawings…− EDUCATION — OpenAI CEO Sam Altman recently told a US podcast that if he was graduating today, “I would feel like the luck…− EDUCATION — I disagree with the decision of lecturers to use artificial intelligence to create teaching materials (‘We co…− BUSINESS — Americans are growing worried about what artificial intelligence portends for their futures. Eight in 10 Amer…− BUSINESS — Accenture has reportedly begun calling its near 800,000 employees “reinventors”, as the consultancy tries to…− LABOR — US workers overwhelmingly support pro-worker policies on artificial intelligence (AI) and view labor unions a…
TruaceTracing the truth around AISunday, July 12, 2026
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TRV-2026-0038Version 1 · Certified

Written 2026-07-12 20:50:17 UTC · current record

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TRUVACE RECORD VERSION
record: TRV-2026-0038
version: 1
kind: certified
reason: Certified into the record
timestamp: 2026-07-12T20:50:17.380688Z
status: published
lens: p_space
sector: health
headline: Mitraclip® system clip delivery system: FDA death report involving AI
dek: The FDA received a death report involving Mitraclip® system clip delivery system, made by Abbott medical. The article, "predicting outcomes in patients with tricuspid regurgitation undergoing transcatheter edge-to-edge repair using an artificial intelligence¿derived risk score", was reviewed. this research article is a retrospective multicenter experience to evaluate and validate a robust, reliable risk score for predicting mortality and clinical outcomes in patients undergoing tricuspid- transcatheter edge-to-edge repa…
gain_reading: (none)
problem_reading: An FDA adverse-event report linked Mitraclip® system clip delivery system to an AI-related death; the report requires investigation and does not by itself establish causality.
limitation: FDA adverse-event reports can be incomplete, duplicated, or unverified and do not establish that a device caused the reported outcome.
tag: Evidence-backed problem
key_points: Device: Mitraclip® system clip delivery system; manufacturer: Abbott medical. | FDA report type: Death. | An adverse-event report is a safety signal, not proof that the device caused the event.
rundown: The article, "predicting outcomes in patients with tricuspid regurgitation undergoing transcatheter edge-to-edge repair using an artificial intelligence¿derived risk score", was reviewed. this research article is a retrospective multicenter experience to evaluate and validate a robust, reliable risk score for predicting mortality and clinical outcomes in patients undergoing tricuspid- transcatheter edge-to-edge repa…

The report is part of FDA’s MAUDE surveillance data. It should be read as a signal for follow-up, not a clinical conclusion or a verified incidence rate.
sources:
- government | FDA MAUDE report 24887354 | https://api.fda.gov/device/event.json?search=mdr_report_key%3A%2224887354%22&sort=date_received%3Adesc&limit=1 | 2026-04-15
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